Gelbard, M. K., Walsh, R., Kaufman, J. J. Collagenase for Peyronie's Disease Experimental Studies, Urol. Res. 10:135-140, 1982. This in vitro pilot study in which Peyronie's plaques were digested in collagenase solution, led to the estimate that the dose required for an effect on Peyronie's plaques in vivo is in the range of 100 to 400 units of Worthington collagenase as a 0.5% solution.
Gelbard, U.S. Pat. No. 4,338,300, issued Jul. 6, 1982, teaches treating Peyronie's disease by administering collagenase directly into the plaques. This patent repeats the data in Gelbard, Walsh and Kaufman, Urol. Res., 10:135-140, 1982 cited above.
Gelbard, M. K., Lindner, A., Kaufman, J. J. The Use of Collagenase in the Treatment of Peyronie's Disease, The Journal of Urology: 134:280-283, 1985. These authors report treatment of 31 men with a history of Peyronie's disease. A dose of 470 Advance Biofactures units [ABC units] per intralesional injection on 3 consecutive days was proposed. The first 6 patients received total doses ranging from 270 to 1,595 units (mean 803). The dose was increased gradually and the next 25 patients received 1,739 to 4,850 units total (mean 2,695). Concentrations of the collagenase were 470 to 620 units per cc in the first 15 patients and then 910 units per cc in the remainder. Of the 31 patients, 20 (65%) reported objective improvement. The authors speculated that the efficacy may be improved by repeated doses, possibly at higher levels
Hamilton, R. G., Mintz, G. R., Gelbard, M. K., Humoral Immune Responses in Peyronie's Disease Patients Receiving Clostridial Collagenase Therapy, The Journal of Urology: 135:641-647, 1986. This study determined human IgG and IgE antibody responses to clostridial collagenase in untreated healthy blood donors and in patients receiving intrapenile injections of collagenase for treatment of Peyronie's disease. Injections were of 3,000 to 12,650 ABC units purified collagenase. Clinical results of effects on the disease were not reported.
Gelbard, M. K., James, K., Riach, P., Dorel, F., Collagenase Versus Placebo in the Treatment of Peyronie's Disease: A Double-Blind Study, The Journal of Urology, 149:56-58, January 1993. Peyronie's disease patients were grouped into 3 categories. Category 1 had a penile bend of 30 degrees or less and/or palpable plaque less than 2 cm. in extent; category 2 displayed 30 to 60 degrees and/or 2 to 4 cm.; category 3 had greater than 60 degrees of angular deviation and/or greater than 4 cm. of palpable plaque. Purified collagenase in the amount of 2,000 advance biofactor units [ABC units] in 0.5 cc of diluent was administered intralesionally in total amounts of 6,000 units to category 1 patients, 10,000 units to category 2, and 14,000 units to category 3. Overall, positive responses were noted in 36% of the treatment group versus 4% in the placebo group. The maximum angular improvement ranged from 15 to 20 degrees. Only 1 positive response out of 8 treated category 3 patients was noted; this was not statistically significant.